Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation

Bryan Cotton

Status and phase: Completed; Phase 3

Conditions: Trauma Injury

Treatments: Biological: Whole Blood; Biological: Platelets; Biological: Plasma; Biological: Cryoprecipitate; Biological: Red Blood Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04704869

ISRCTN14998314 (Registry Identifier)

HSC-MS-19-0272

Details and patient eligibility

About

The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).

Enrollment: 1,604 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is judged to be an adult (according to local practice, e.g. 16 years or older in UK) and has sustained severe traumatic injury. In the event the age is unknown, estimated body weight ≥50 kg.
• The patient is deemed by the attending clinician to have on-going active hemorrhage AND REQUIRES Activation of the local major hemorrhage protocol for management of severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood component

Exclusion criteria

• The patient has been transferred from another hospital
• The trauma team leader deems the injuries incompatible with life
• More than 3 hours have elapsed from the time of injury
• Prisoner (as defined as someone admitted from a correctional facility)
• Known "Do Not Resuscitate" orders
• Enrolled in a concurrent ongoing interventional, randomized clinical trial
• Patients who wear "opt out" bracelet for study
• Obvious pregnancy
• Severely burned

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,604 participants in 2 patient groups

Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)

Experimental group

Description:

Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).

Treatment:

Biological: Red Blood Cells

Biological: Cryoprecipitate

Biological: Plasma

Biological: Platelets

Biological: Whole Blood

Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood)

Active Comparator group

Description:

Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.

Treatment:

Biological: Red Blood Cells

Biological: Plasma

Biological: Platelets

Biological: Whole Blood